Susanne Manz
Quality and Compliance Expert / Auditor for Medical Devices, Manz Consulting, Inc.
This 6-hour virtual seminar is an essential guide on how to create and implement an efficient and effective internal audit program. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to self-identify areas of non-compliance.
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This 4-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company.
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The FDA has spent years updating the Quality System Regulation (QSR 21 CFR, Part 820) and has finally published draft regulation on February 22, 2022 to harmonize the QSR with ISO 13485:2016. If you’re thinking of improvements to your CAPA process, this is the right time to incorporate ISO13485. This seminar will help you prepare for upcoming changes to the QSR and improve your CAPA process.
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This 6-hour virtual seminar can help you understand your responsibilities in terms of Purchasing Controls and Supplier Management enabling you to provide safe and effective products to your customers.
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This 6 -hour virtual seminar will help you to develop a Quality Management System (QMS) for Medical Device Companies.
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This 6-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process
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This Virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. You'll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this seminar is for you.
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This Virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. You'll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this seminar is for you.
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Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
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Validation is an important element of the Quality System Regulations and ISO13485.
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CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.Not only do they fail to achieve necessary improvements, they waste precious time and resources.
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Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection.
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